BEUDAMED
    14 results · 18ms · Sources: EU EUDAMED, US FDA

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    CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05714464007172·SONIC RADIANT 60 MNR T R BL DEMO

    HEALIX ADVANCE ORTHOCORD

    FDA UDI
    Medos International Sàrl·10886705021451·HEALIX ADVANCE PEEK 3 SUTURE ANCHOR w/ORTHOCORD...

    BD Difco™ Neisseria Meningitidis Antiserum Group D

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902223115·Vial N Meningitidis Antiserum Grp D

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113577·PS-C Insert, Size 3 x 11mm

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113288·STAB KNIFE 22.5 DEGREE (BX/5)

    GC-3000E DIGITAL COLPOSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RHINOSTREAM RHINOMANOMETER MODULE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Ambassador Cervical Plate System

    FDA UDI
    Choice Spine, LP·00840996161220·AMBASSADOR,DRILL,2.3x11

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 24, 2011

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 4, 2014

    GYNECARE TVT ABBREVO CONTINENCE SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 12, 2013

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014